Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients W… (NCT03040726) | Clinical Trial Compass
CompletedPhase 2/3
Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer
United States53 participantsStarted 2017-05-03
Plain-language summary
This randomized phase II/III trial studies how well netupitant and palonosetron hydrochloride works in preventing chronic nausea and vomiting in patients with cancer. Netupitant and palonosetron hydrochloride may reduce nausea and vomiting.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of cancer
* Chronic nausea over the past 4 weeks
* Average nausea numeric rating scale \>= 4/10 over the past 5 days at screening
* Outpatient at MD Anderson Cancer Center
* Karnofsky performance status \>= 50%
* Age 18 or older
* Able to complete study assessments, including keeping a daily diary
Exclusion Criteria:
* Delirium (i.e. Memorial Delirium Rating Scale \> 13)
* Clinical evidence of bowel obstruction at the time of study enrollment
* Expected to use other 5HT3 antagonists or NK1 antagonists for prophylaxis during the study
* Continuation of over-the-counter therapies for nausea and/or vomiting during the study
* On cytotoxic chemotherapy in the high/moderate/low emetogenic risk categories or oral antineoplastic agents in the high or moderate emetogenic risk categories according to the latest National Comprehensive Cancer Network (NCCN) guideline within 2 weeks of study enrollment
* On scheduled potent CYP3A4 inducers at the time of study enrollment (avasimibe, carbamazepine, phenytoin, rifampin, efavirenz, nevirapine, barbiturates, systemic glucocorticoids, modafinil, oxcarbazine, phenobarbital, pioglitazone, rifabutin, St. John's wort, troglitazone)
* On scheduled CYP3A4 substrates with narrow safety range at the time of study enrollment (alfentanil, cyclosporine, dihydroergotamine, ergotamine, pimozide, quinidine, sirolimus, tacrolimus)
* On scheduled strong or moderate CYP3A4 inhibitors (boceprevir, clarithromycin, conivaptan, …
What they're measuring
1
Change in Nausea Numerical Rating Scale (NRS) Between Day 5 and Day 15